Company ยท DE
Heidelberg Engineering GmbH
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2026. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (2 in 12 months)
3recalls (1 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 11, 2026 | K261019 | ANTERION Heidelberg Engineering GmbH, DE | OBO |
| May 7, 2026 | K253837 | SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module Heidelberg Engineering GmbH, DE | OBO |
| May 12, 2025 | K250868 | SPECTRALIS HRA+OCT and variants Heidelberg Engineering GmbH, DE | OBO |
| Dec 13, 2024 | K240924 | Anterion Heidelberg Engineering GmbH, DE | OBO |
| Oct 11, 2024 | K241163 | SPECTRALIS with Flex Module Heidelberg Engineering GmbH, DE | OBO |
| Jul 1, 2024 | K240221 | SPECTRALIS HRA+OCT and variants Heidelberg Engineering GmbH, DE | OBO |
| Oct 20, 2023 | K223557 | SPECTRALIS HRA+OCT and variants Heidelberg Engineering GmbH, DE | OBO |
| Oct 11, 2023 | K230897 | Anterion Heidelberg Engineering GmbH, DE | OBO |
| Nov 5, 2021 | K211817 | Anterion Heidelberg Engineering GmbH, DE | OBO |
| Sep 9, 2020 | K201252 | Spectralis HRA+OCT and variants Heidelberg Engineering GmbH, DE | OBO |
| Sep 26, 2019 | K192391 | Spectralis HRA+OCT and Variants Heidelberg Engineering GmbH, DE | OBO |
| Oct 18, 2018 | K182569 | Spectralis HRA+OCT and variants with High Magnification Module Heidelberg Engineering GmbH, DE | OBO |
| Sep 13, 2018 | K181594 | Spectralis HRA+OCT and variants with OCT Angiography Module Heidelberg Engineering GmbH, DE | OBO |
| Aug 30, 2018 | K173648 | Spectralis HRA + OCT and variants Heidelberg Engineering GmbH, DE | OBO |
| Nov 1, 2017 | K172649 | Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Heidelberg Engineering GmbH, DE | OBO |
| May 6, 2016 | K152205 | Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spect Heidelberg Engineering GmbH, DE | OBO |
| Oct 25, 2012 | K121993 | SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT Heidelberg Engineering GmbH | OBO |
| Nov 8, 2011 | K113129 | SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM) Heidelberg Engineering GmbH, DE | OBO |
| Oct 1, 2010 | K101223 | SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA Heidelberg Engineering | OBO |
| Oct 31, 2006 | K063191 | HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT Heidelberg Engineering, DE | OBO |
| Jan 13, 2006 | K052935 | HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT) Heidelberg Engineering, DE | MXK |
| Oct 13, 2004 | K042742 | HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM) Heidelberg Engineering, DE | MXK |
| Jul 29, 1997 | K971671 | HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C) Heidelberg Engineering, DE | HLI |
| Nov 14, 1994 | K944261 | RETINA ANGIOGRAPH Heidelberg Engineering, DE | HLI |
| Nov 14, 1994 | K943956 | RETINA TOMOGRAPH AND FLOWMETER Heidelberg Engineering, DE | HLI |
| Nov 14, 1994 | K943955 | RETINA FLOWMETER Heidelberg Engineering, DE | HLI |
| Sep 27, 1991 | K912891 | HEIDELBERG RETINA TOMOGRAPH Heidelberg Engineering | HLI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2026 | Heidelberg Engineering GmbH Brand Name: Heidelberg Engineering GmbH
Product Name: SPECTRALIS with Flex Module
Model/Catalog Number: S3610, S2610, S2000, S1610
multimodal imaging platform optimized for the posterior segment of t Open, Classified |
OBO | K181594 |
| Jul 3, 2019 | Heidelberg Engineering GmbH SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device. Terminated |
OBO | K181594 |
| Dec 8, 2017 | Heidelberg Engineering Widefield OCT software feature for the Spectralis HRA+OCT and variants Terminated |
OBO | None listed |